Nancy Chinchilla Email & Phone Number

Arlington, Tx, Us

Abbott Molecular Division

99 Regency Pkwy, Ste 103, Mansfield, Tx 76063

Supported IT Data Integrity Projects for Novartis pharmaceutical facility in Fort Worth, TX

Arlington, Tx

Assisted the Director of Global Quality/Regulatory Affairs in the day-to-day management, coordination and administration of the Joerns Healthcare Global Quality Management System. Help facilitate achievement of individual plant objectives of quality, safety, efficiency, productivity, customer service and regulatory compliance. Managed the change management systems for Document Control and SAP master material life cycle data.

Provide leadership and strategic direction for a division level, Quality Assurance organization. Managed implementation and changes for applications on electronic systems that service the Abbott Nutrition Quality System. Developed and presented long-term strategic recommendations for IT application enhancements. Analyzed critical path problems and developed alternate solutions to keep projects on track, while fostering cooperation among affected business units and organizational elements.Key Accomplishments:* Used extensive knowledge of FDA and other global regulatory requirements to ensure Quality Assurance applications and other activities improved compliance.* Championed the need to build a Business Intelligence strategy for Quality Assurance, highlighting the critical information it would provide for all levels of management. * Managed special team to develop methods to capture the extent of ongoing costs of the existing poor quality for QA applications. * Restructured Software Quality Assurance to be involved earlier in the software life cycle process, resulting in the ability of the team to address compliance and design issues earlier in the process. * Developed strategy to obtain funding to hire contract resources with experience and competencies that better supported the business objectives.* Led the effort to perform productivity studies to expose added person-hour costs of design deficiencies and to get deficiencies corrected. * Managed successful global deployment of Dassault Systèmes ENOVIA MatrixOne complaint module to 40 countries. * Led campaign to look beyond upgrading current legacy complaint system, providing a proposal to select outside vendor SpartaSystems' TrackWise, which is currently being implemented.

AN representative on interdivisional team tasked with implementing a multi-million dollar global complaint module project. Responsible for ensuring QA Subject Matter Experts (SME) design requirements are properly incorporated to improve compliance and productivity.

Manager of Global Customer Service Quality Systems and Change Control Process that assures compliance with regulatory/quality requirements improves efficiency and enhances customer satisfaction. Primary interface with IT to manage system implementations and changes that support customer service teams worldwide.Key Accomplishment:* Provided quality guidance to Project Manager, Core Customer Service Project Team and Executive Management Steering Committee on customized Salesforce.com customer relationship management system implementation for ADC Commercial organization.* Improved troubleshooting guideline (TSG) change control process to reduce cycle time by 28%, exceeding department goal.* Streamlined TSG business review and approval process to decrease turnaround from 24 to 17 days, resulting in a 29% cycle time improvement.* Implemented a competitive bidding process for TSG translation quotes resulting in a cost savings of $30K (38% reduction in cost) for ADC Worldwide Customer Service.

· Project manager for QA division-wide electronic systems. Key Accomplishment:* Executed the global deployment strategy for an integrated document management system for AV, by 4Q08, resulting in a standardized system for document control, currently in use.* Directed the Project Manager for AV Universal Product Numbering strategy resulting in Finished Goods Part Numbering procedure, which defines the process for the creation of new-finished goods part numbers, descriptions and product hierarchy assignment; including modifications to product descriptions, product hierarchies and Universal Product Numbers by 4Q08. * Actively participated on Guidant and Abbott Integration Team to evaluate CAPA/Documentation/ Training and Customer Complaint IT systems; provided analysis of systems to determine division Quality System infrastructure configuration.

· Directed the development of Quality System and business tools applications. Developed Product Quality Tracking database to monitor status and turn around time for risk evaluations, internal complaint investigations, Customer and Field Service Communications.· Collected and conducted preliminary analysis of metrics data for Executive Management Review (EMR) & Corrective Action and Preventive Action (CAPA) Meetings.· Facilitated meetings with upper management and end users to identify business processes and assist in improvements to the processes.· Supplied audit responses and support.Key Accomplishments:* Developed new complaint handling strategic initiative and Product Quality Area Management Review Board at the Abbott Diagnostics Division (ADD) Dallas site. Transformed the management of product issues from a reactive mode to one that proactively provides meaningful data to assure superior product performance for customers.

· Project management of System Level Assessments and Investigations as directed by division executive management.· Participated in cross-functional risk management teams to resolve post-market product QA issues.Key Accomplishment:* Led the design team that developed a validated Executive Management Review (EMR) Meetings database. The database resulted in improved compliance of tracking and retention of EMR records, and was implemented at the ADD Chicago site in 2002 and at six additional ADD sites worldwide. Audits of this database resulted in zero observations. * Successfully managed a project that developed methods for global metrics collection and process improvements for the Division Quality Systems organization. Significantly reduced metrics processing time by more than 30 percent, and improved data integrity by implementing a validated process.

Customer Advocate & Liaison for R&D IS Operations at the Dallas site, responsible for:· Recruited, hired, trained, and supervised a technical support staff of five people who serviced over 500 users.· Assessed individual staff member’s performance; made merit recommendations based on statistical and subjective review.· Assisted internal customer base to maintain IS expense budget within plan and determined capital needs for financial updates, by identifying and providing cost effective solutions for customer IS needs through gathering requirements and performing gap analysis.Key Accomplishments:* Standardized desktop configurations and streamlined documentation, raising productivity 5 percent (effectively saving $40,000 per year for the group).* Optimized the use of core business service providers by cultivating partnerships with internal/external organizations to support R&D IS strategic business needs.* Pioneered the company’s first support staff empowerment effort. Resulted in customer satisfactory rating of 4.5 on a 1.0 to 5.0 scale and established the baseline goal for IS Service Level Agreements (SLA) on the Dallas site.

Responsible for coordinating all new product Management Reviews between Chicago and Dallas sites. Played an integral role in the establishment of division procedures for new instrument release. Quality representative for Divisional new product development and process improvement teams.

New product coordinator for X-Systems business unit. Developed and updated all operations manuals.

Guided R&D and Technical Support in the development of new reagent documentation. Managed the tracking system for new and existing reagent manufacturing documentation.

Created a new sample storage system, which enabled easy access to all reagent stability test samples. Served as liaison between Puerto Rico and Dallas in the processing, testing and data analysis of reagent stability samples.

Developed and implemented a system for efficient use of documentation and work flow control process in the X Systems Microbiology Lab. Promoted to senior lab position after first year.

Arlington, Tx

Responsible for performing all microbiology tests on concentrate products. Ensure that proper quality control procedures are followed during the production of concentrate batches. This is accomplished through equipment swabs and product sampling. Carry out all microbiology tests, evaluated results and monitored possible problem areas.

Ba, Psychology

Education record